Valsartan and Valsartan HCT from STADA Arzneimittel GmbH

Recall | Medicines | 05/07/2018

The marketing authorization holder has informed its supplied customers in a letter dated 05.07.2018 that an impurity was detected during the review at the active ingredient level. This impurity is classified as potentially carcinogenic. Therefore, a recall of "Valsartan STADA Film Tablets" in the strengths 80 mg, 160 mg, 320 mg and "Valsartan HCT STADA Film Tablets" in the strengths 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg will be carried out exclusivelyfor the above mentioned batches.

Name of the medicinal product 1. Valsartan STADA 80 mg Filmtabletten
2. Valsartan STADA 160 mg Filmtabletten
3. Valsartan STADA 320 mg Filmtabletten
4. Valsartan HCT STADA 160 mg/12,5 mg Filmtabletten
5. Valsartan HCT STADA 160 mg/25 mg Filmtabletten
6. Valsartan HCT STADA 320 mg/12,5 mg Filmtabletten
7. Valsartan HCT STADA 320 mg/25 mg Filmtabletten
Marketing authorisation number(s) 1. 1-28990
2. 1-28991
3. 1-28992
4. 1-29451
5. 1-29454
6. 1-29452
7. 1-29455
Marketing authorisation holder STADA Arzneimittel GmbH
Batch number(s) 1. 70488, 73213
2. 64010V, 73338
3. 72872
4. 64003V, 70414
5. 70584, 74195
6. 70716
7. 65237
Classification of the recall1
BASG reference number INS - 640.001 - 2580
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